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Trial record 15 of 74 for:    Codeine AND Acetaminophen

A Study to Asses the Effect of MK0663 in the Treatment of Patients With Postoperative Dental Pain (0663-092)

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ClinicalTrials.gov Identifier: NCT00694369
Recruitment Status : Completed
First Posted : June 10, 2008
Results First Posted : January 29, 2010
Last Update Posted : March 21, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE June 6, 2008
First Posted Date  ICMJE June 10, 2008
Results First Submitted Date  ICMJE November 13, 2009
Results First Posted Date  ICMJE January 29, 2010
Last Update Posted Date March 21, 2016
Study Start Date  ICMJE June 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2010)
Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6) [ Time Frame: Over the first 6 hours post the initial Day 1 dose of the study medication ]
TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point Likert scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24.
Original Primary Outcome Measures  ICMJE
 (submitted: June 9, 2008)
Safety and tolerability of MK0663 and overall analgesic effect as measured by the total pain relief score (TOPAR) [ Time Frame: Over the 6 hour post dose period ]
Change History Complete list of historical versions of study NCT00694369 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2010)
Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication [ Time Frame: At 24 hours post the initial Day 1 dose of the study medication ]
Patient's Global Assessment of Study Medication was on 0- to 4- point scale, with 0=Poor, and 4=Excellent for patient's rating of the study medication for pain.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2008)
Global assessment of satisfaction with study drug [ Time Frame: Over the 24 hour post dose period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Asses the Effect of MK0663 in the Treatment of Patients With Postoperative Dental Pain (0663-092)
Official Title  ICMJE A Phase III Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Multiple-Dose Clinical Trial to Study the Efficacy and Safety of MK0663/Etoricoxib 90 and 120 mg, Ibuprofen 600 mg, and Acetaminophen 600 mg/Codeine 60 mg in the Treatment of Patients With Postoperative Dental Pain
Brief Summary The purpose of this study is to compare the pain relieving effect of different doses of MK0663 with placebo and other pain relievers/analgesics in patients with postoperative dental pain. Pain intensity and relief will be measured by the total pain relief score (TOPAR) and patient evaluation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Dental Pain
Intervention  ICMJE
  • Drug: Comparator: etoricoxib
    etoricoxib 90 mg; 120 mg (once daily) over three days.
  • Drug: Comparator: ibuprofen
    ibuprofen 2400 mg (600 mg Q6h) over three Days
  • Drug: Comparator: acetaminophen + codeine
    acetaminophen 2400 mg/codeine 240 mg (600/60 mg Q6h) over three Days
  • Drug: Comparator: placebo
    matching placebo over three Days
Study Arms  ICMJE
  • Experimental: 1
    etoricoxib 90 mg
    Intervention: Drug: Comparator: etoricoxib
  • Experimental: 2
    etoricoxib 120 mg
    Intervention: Drug: Comparator: etoricoxib
  • Active Comparator: 3
    ibuprofen 2400 mg
    Intervention: Drug: Comparator: ibuprofen
  • Active Comparator: 4
    acetaminophen 2400 mg/codeine 240 mg
    Intervention: Drug: Comparator: acetaminophen + codeine
  • Placebo Comparator: 5
    Matching Placebo
    Intervention: Drug: Comparator: placebo
Publications * Brown JD, Daniels SE, Bandy DP, Ko AT, Gammaitoni A, Mehta A, Boice JA, Losada MC, Peloso PM. Evaluation of multiday analgesia with etoricoxib in a double-blind, randomized controlled trial using the postoperative third-molar extraction dental pain model. Clin J Pain. 2013 Jun;29(6):492-8. doi: 10.1097/AJP.0b013e318260c144.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2010)
588
Original Estimated Enrollment  ICMJE
 (submitted: June 9, 2008)
460
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must be scheduled to have 2 or more third molars removed, at least 1 of which is partially embedded in bone and is impacted in the lower jaw
  • Patients must be experiencing moderate to severe pain following the dental procedure

Exclusion Criteria:

  • Previous molar extraction within the past 45 days
  • Personal or family history of an inherited bleeding disorder
  • Uncontrolled high blood pressure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00694369
Other Study ID Numbers  ICMJE 0663-092
MK0663-092
2008_506
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP